Below are links to helpful guidance, forms, and websites that pertain to the conduct of human subjects research.

HRPP Guidance Documents:

• DUA/DTA Decision Tree
• Adding Non-UTSW Affiliated Individuals
• Annual Updates FAQs
• Informed Consent Process
• Enrolling and Consenting Non-English Speaking Subjects
• Research Participant Brochure
• Table: Reportable Event Guidance
• Translation and Support Service
• 2.7 EXCEPTION FROM INFORMED CONSENT GUIDANCE
• 4.2 GUIDANCE FOR ADVERTISING TO RESEARCH SUBJECTS
• 9.5 REPORTABLE EVENTS GUIDANCE
• 10.0 GLOSSARY OF HUMAN RESEARCH TERMS
• ISAC Review of Human Research 
• Clinical Trials Ads & Social Media CMPA Review 
• eIRB Help Text Document - Placeholder
• Evaluation of Deviations - Decision Tree

HRPP Policy Memos:

• IRB Review of Pregnant Partners
• Prompt Reporting of Unanticipated Problems to the IRB
• FWA Letter/Documentation
• Non-Affiliated Study Personnel

Tip Sheets

• Exempt Tip Sheet-Pre 2018 Common Rule (before January 21, 2019)
• Exempt Categories NEW Common Rule (on/after January 21, 2019)
• Requesting performance site approval tip sheet
• NIH Data Management and Sharing (DMS) Policy
• "I'd like to share Data and/or Materials with an External Entity."

Reportable Event Forms

• Deviation Form (used for recording individual deviations)
• Deviation Tracking Log (used for summarizing deviations collectively)
  • Sample Deviation Tracking Log (with examples) 
• UPIRSO Form (used for recording individual unanticipated problems(UPs))
• UPIRSO Tracking Log (used for summarizing UPs collectively)

Other helpful links:

• 21 CFR Part 11 Compliance (Intranet only)
• Export Control (Intranet only)
• HIPAA (NIH Privacy Rule and Research) (Health Insurance Portability & Accountability Act)
• Information Security Information (Intranet only)
• IRB OHRP/FDA Registration Information
• IRB/CITI Training Requirements